Rotational intravascular ultrasound probe with an active spinning element

ABSTRACT

An intravascular ultrasound probe is disclosed, incorporating features for utilizing an advanced transducer technology on a rotating transducer shaft. In particular, the probe accommodates the transmission of the multitude of signals across the boundary between the rotary and stationary components of the probe required to support an advanced transducer technology. These advanced transducer technologies offer the potential for increased bandwidth, improved beam profiles, better signal to noise ratio, reduced manufacturing costs, advanced tissue characterization algorithms, and other desirable features. Furthermore, the inclusion of electronic components on the spinning side of the probe can be highly advantageous in terms of preserving maximum signal to noise ratio and signal fidelity, along with other performance benefits.

BACKGROUND

Intravascular Ultrasound (IVUS) has become an important interventionaldiagnostic procedure for imaging atherosclerosis and other vesseldiseases and defects. In the procedure, an IVUS catheter is threadedover a guidewire into a blood vessel of interest, and images areacquired of the atherosclerotic plaque and surrounding area usingultrasonic echoes. This information is much more descriptive than thetraditional standard of angiography, which shows only a two-dimensionalshadow of the vessel lumen. Some of the key applications of IVUSinclude: determining a correct diameter and length of a stent to choosefor dilating an arterial stenosis, verifying that a post-stentingdiameter and luminal cross-section area are adequate, verifying that astent is well apposed against a vessel wall to minimize thrombosis andoptimize drug delivery (in the case of a drug eluting stent) andidentifying an exact location of side-branch vessels. In addition, newtechniques such as virtual histology (RF signal-based tissuecharacterization) show promise of aiding identification of vulnerableplaque (i.e., plaque which is prone to rupture and lead to onset of aheart attack).

There are two types of IVUS catheters commonly in use:mechanical/rotational IVUS catheters and solid state catheters. In arotational IVUS catheter, a single transducer consisting of apiezoelectric crystal is rotated at approximately 1800 revolutions perminute while the element is intermittently excited with an electricalpulse. This excitation causes the element to vibrate at a frequencydependent upon the particulars of the transducer design. Depending onthe dimensions and characteristics of the transducer, this operatingfrequency is typically in the range of 8 to 50 MHz. In general terms, ahigher frequency of operation provides better resolution and a smallercatheter, but at the expense of reduced depth of penetration andincreased echoes from the blood (making the image more difficult tointerpret). A lower frequency of operation is more suitable for IVUSimaging in larger vessels or within the chambers of the heart.

The rotational IVUS catheter has a drive shaft disposed within thecatheter body. The transducer is attached to the distal end of the driveshaft. The typical single element piezoelectric transducer requires onlytwo electrical leads, with this pair of leads serving two separatepurposes: (1) delivering the intermittent electrical transmit pulses tothe transducer, and (2) delivering the received electrical echo signalsfrom the transducer to the receiver amplifier (during the intervalsbetween transmit pulses). The IVUS catheter is removably coupled to aninterface module, which controls the rotation of the drive shaft withinthe catheter body and contains the transmitter and receiver circuitryfor the transducer. Because the transducer is on a rotating drive shaftand the transmitter and receiver circuitry is stationary, a device mustbe utilized to carry the transmit pulse and received echo across arotating interface. This can be accomplished via a rotary transformer,which comprises two halves, separated by a narrow air gap that permitselectrical coupling between the primary and secondary windings of thetransformer while allowing relative motion (rotation) between the twohalves. The spinning element (transducer, electrical leads, anddriveshaft) is attached to the spinning portion of the rotarytransformer, while the stationary transmitter and receiver circuitrycontained in the interface module are attached to the stationary portionof the rotary transformer.

The other type of IVUS catheter is a solid state (or phased array)catheter. This catheter has no rotating parts, but instead includes anarray of transducer elements (for example 64 elements), arrayed in acylinder around the circumference of the catheter body. The individualelements are fired in a specific sequence under the control of severalsmall integrated circuits mounted in the tip of the catheter, adjacentto the transducer array. The sequence of transmit pulses interspersedwith receipt of the echo signals provides the ultrasound data requiredto reconstruct a complete cross-sectional image of the vessel, similarin nature to that provided by a rotational IVUS device.

Currently, most IVUS systems rely on conventional piezoelectrictransducers, built from piezoelectric ceramic (commonly referred to asthe crystal) and covered by one or more matching layers (typically thinlayers of epoxy composites or polymers). Two advanced transducertechnologies that have shown promise for replacing conventionalpiezoelectric devices are the PMUT (Piezoelectric MicromachinedUltrasonic Transducer) and CMUT (Capacitive Micromachined UltrasonicTransducer). PMUT and CMUT transducers may provide improved imagequality over that provided by the conventional piezoelectric transducer,but these technologies have not been adopted for rotational IVUSapplications due to the larger number of electrical leads they require,among other factors.

There are many potential advantages of these advanced transducertechnologies, some of which are enumerated here. Both PMUT and CMUTtechnologies promise reduced manufacturing costs by virtue of the factthat these transducers are built using wafer fabrication techniques tomass produce thousands of devices on a single silicon wafer. This is animportant factor for a disposable medical device such as an IVUScatheter. These advanced transducer technologies provide broad bandwidth(>100%) in many cases compared to the 30-50% bandwidth available fromthe typical piezoelectric transducer. This broader bandwidth translatesinto improved depth resolution in the IVUS image, and it may alsofacilitate multi-frequency operation or harmonic imaging, either ofwhich can help to improve image quality and/or enable improvedalgorithms for tissue characterization, blood speckle reduction, andborder detection. Advanced transducer technologies also offer thepotential for improved beam characteristics, either by providing afocused transducer aperture (instead of the planar, unfocused aperturecommonly used), or by implementing dynamically variable focus with anarray of transducer elements (in place of the traditional singletransducer element).

BRIEF SUMMARY

The present invention provides the enabling technology allowing advancedtransducer technology to be introduced into a rotational IVUS catheter.This in turn will provide improved image quality and support advancedsignal processing to facilitate more accurate diagnosis of the medicalcondition within the vessel. All of this can be achieved in acost-effective way, possibly at a lower cost than the conventionaltechnology.

Embodiments of an intravascular ultrasound probe are disclosed herein.The probe has features for utilizing an advanced transducer technologyon a rotating transducer shaft. In particular, the probe accommodatesthe transmission of the multitude of signals across the boundary betweenthe rotary and stationary components of the probe required to support anadvanced transducer technology. These advanced transducer technologiesoffer the potential for increased bandwidth, improved beam profiles,better signal to noise ratio, reduced manufacturing costs, advancedtissue characterization algorithms, and other desirable features.Furthermore, the inclusion of electronic components on the spinning sideof the probe can be highly advantageous in terms of preserving maximumsignal to noise ratio and signal fidelity, along with other performancebenefits.

In a disclosed embodiment, a rotational intravascular ultrasound probefor insertion into a vasculature is described. The rotationalintravascular ultrasound probe can comprise an elongate catheter, anelongate transducer shaft, a spinning element, and a motor. The elongatecatheter can have a flexible body. The elongate transducer shaft can bedisposed within the flexible body and can have a drive cable and atransducer coupled to the drive cable. The spinning element can becoupled to the transducer shaft and can have an electronic componentcoupled thereto that is in electrical contact with the transducer. Amotor may be coupled to the spinning element for rotating the spinningelement and the transducer shaft.

In another disclosed embodiment, an interface module for a rotationalintravascular ultrasound probe for insertion into a vasculature isdescribed. The interface module can comprise a connector, a spinningelement, and a motor. The connector can be used for attachment to acatheter having a transducer shaft with a transducer. The spinningelement can be coupled to the connector and can have an electroniccomponent coupled thereto that is in electrical contact with theconnector. A motor may be coupled to the spinning element for rotatingthe spinning element.

In yet another disclosed embodiment, an interface module for arotational intravascular ultrasound probe for insertion into avasculature is described. The interface module can comprise a printedcircuit board, a connector, a spinning element, and a motor. Theconnector can be used for attachment to a catheter having a transducershaft with a transducer. The spinning element can be coupled to theconnector. The spinning element has more than two signal pathwayselectrically connecting the spinning element to the connector. A motormay be coupled to the spinning element for rotating the spinningelement.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a simplified fragmentary diagrammatic view of a rotationalIVUS probe;

FIG. 2 is a simplified fragmentary diagrammatic view of an interfacemodule and catheter for the rotational IVUS probe of FIG. 1incorporating basic ultrasound transducer technology;

FIG. 3 is a simplified fragmentary diagrammatic view of an embodiment ofan interface module and catheter for the rotational IVUS probe of FIG. 1incorporating an advanced ultrasound transducer technology;

FIG. 4 is a simplified fragmentary diagrammatic view of anotherembodiment of an interface module and catheter for the rotational IVUSprobe of FIG. 1 incorporating an advanced ultrasound transducertechnology;

FIG. 5 is a simplified fragmentary diagrammatic view of anotherembodiment of an interface module and catheter for the rotational IVUSprobe of FIG. 1 incorporating an advanced ultrasound transducertechnology; and

FIG. 6 is a simplified fragmentary diagrammatic view of anotherembodiment of an interface module and catheter for the rotational IVUSprobe of FIG. 1 incorporating an advanced ultrasound transducertechnology.

DETAILED DESCRIPTION

Turning to the figures, representative illustrations of rotationalintravascular ultrasound (IVUS) probes, some of which include activespinning elements, are shown therein. An active spinning element canincrease the number of signal paths available for the operation of thetransducer so that advanced transducer technologies, such as PMUT(Piezoelectric Micromachined Ultrasonic Transducer) and CMUT (CapacitiveMicromachined Ultrasonic Transducer), can be utilized with a rotationalIVUS probe. In addition, an active spinning element can include activeelectronics on the rotary side of the probe.

Referring specifically to FIG. 1, a rotational intravascular ultrasoundprobe 100 for insertion into a patient for diagnostic imaging is shown.The probe 100 comprises a catheter 101 having a catheter body 102 and atransducer shaft 104. The catheter body 102 is flexible and has both aproximal end portion 106 and a distal end portion 108. The catheter body102 is a sheath surrounding the transducer shaft 104. For explanatorypurposes, the catheter body 102 in FIG. 1 is illustrated as visuallytransparent such that the transducer shaft 104 disposed therein can beseen, although it will be appreciated that the catheter body 102 may ormay not be visually transparent. The transducer shaft 104 is flushedwith a sterile fluid, such as saline, within the catheter body 102. Thefluid serves to eliminate the presence of air pockets around thetransducer shaft 104 that adversely affect image quality. The fluid canalso act as a lubricant. The transducer shaft 104 has a proximal endportion 110 disposed within the proximal end portion 106 of the catheterbody 102 and a distal end portion 112 disposed within the distal endportion 108 of the catheter body 102.

The distal end portion 108 of the catheter body 102 and the distal endportion 112 of the transducer shaft 104 are inserted into a patientduring the operation of the probe 100. The usable length of the probe100 (the portion that can be inserted into a patient) can be anysuitable length and can be varied depending upon the application. Thedistal end portion 112 of the transducer shaft 104 includes a transducersubassembly 118.

The proximal end portion 106 of the catheter body 102 and the proximalend portion 110 of the transducer shaft 104 are connected to aninterface module 114 (sometimes referred to as a patient interfacemodule or PIM). The proximal end portions 106, 110 are fitted with acatheter hub 116 that is removably connected to the interface module114.

The rotation of the transducer shaft 104 within the catheter body 102 iscontrolled by the interface module 114, which provides a plurality ofuser interface controls that can be manipulated by a user. The interfacemodule 114 also communicates with the transducer subassembly 118 bysending and receiving electrical signals to and from the transducersubassembly 118 via wires within the transducer shaft 104. The interfacemodule 114 can receive, analyze, and/or display information receivedthrough the transducer shaft 104. It will be appreciated that anysuitable functionality, controls, information processing and analysis,and display can be incorporated into the interface module 114.

The transducer shaft 104 includes a transducer subassembly 118, atransducer housing 120, and a drive cable 122. The transducersubassembly 118 is coupled to the transducer housing 120. The transducerhousing 120 is attached to the drive cable 122 at the distal end portion112 of the transducer shaft 104. The drive cable 122 is rotated withinthe catheter body 102 via the interface module 114 to rotate thetransducer housing 120 and the transducer subassembly 118. Thetransducer subassembly 118 can be of any suitable type, including butnot limited to one or more advanced transducer technologies such as PMUTor CMUT. The transducer subassembly 118 can include either a singletransducer or an array.

FIG. 2 shows a rotational IVUS probe 200 utilizing a common spinningelement 232. The probe 200 has a catheter 201 with a catheter body 202and a transducer shaft 204. As shown, the catheter hub 216 is near theproximal end portion 206 of the catheter body 202 and the proximal endportion 210 of the transducer shaft 204. The catheter hub 216 includes astationary hub housing 224, a dog 226, a connector 228, and bearings230. The dog 226 mates with a spinning element 232 for alignment of thehub 216 with the interface module 214 and torque transmission to thetransducer shaft 204. The dog 226 rotates within the hub housing 224utilizing the bearings 230. The connector 228 in this figure is coaxial.The connector 228 rotates with the spinning element 232, describedfurther herein.

As shown, the interior of the interface module 214 includes a motor 236,a motor shaft 238, a printed circuit board (PCB) 240, the spinningelement 232, and any other suitable components for the operation of theIVUS probe 200. The motor 236 is connected to the motor shaft 238 torotate the spinning element 232. The printed circuit board 240 can haveany suitable number and type of electronic components 242, including butnot limited to the transmitter and the receiver for the transducer.

The spinning element 232 has a complimentary connector 244 for matingwith the connector 228 on the catheter hub 216. As shown, the spinningelement 232 is coupled to a rotary portion 248 of a rotary transformer246. The rotary portion 248 of the transformer 246 passes the signals toand from a stationary portion 250 of the transformer 246. The stationaryportion 250 of the transformer 246 is wired to the transmitter andreceiver circuitry on the printed circuit board 240.

The transformer includes an insulating wire that is layered into anannular groove to form a two- or three-turn winding. Each of the rotaryportion 250 and the stationary portion 248 has a set of windings, suchas 251 and 252 respectively. Transformer performance can be improvedthrough both minimizing the gap between the stationary portion 250 andthe rotary portion 248 of the transformer 246 and also by placing thewindings 251, 252 as close as possible to each other.

Advanced transducer technologies can require more than the twoconductive signal lines that a single piezoelectric transducer utilizeson a conventional rotational IVUS probe. For example, in addition tosignal pathways for ultrasound information communicated with thetransducer, certain advanced transducer technologies also require apower supply in order to operate. In order to pass the necessarymultiple of signals between the advanced transducer technology and theinterface module, a suitable structure may be needed to transmitultrasound signals, power, and any other suitable signals across theboundary between the rotating and stationary mechanical components.Particularly for ultrasound signals, the mode of transmission must alsomaintain reliable signal quality, without excess noise, sufficient forthe interface module to form a reliable image of the target tissue fromthe sensitive ultrasound signals. It will be appreciated that anysuitable signals can be communicated across the boundary between therotating and stationary mechanical components including, but not limitedto, A-scan RF data, power transmit pulses, low amplitude receivesignals, DC power and/or bias, AC power, and/or various control signals.The signal transfer across the boundary between the rotating andstationary mechanical components can have high frequency capability andbroadband response.

Multiple signal transfer pathways are presented herein for communicatingsignals across the boundary of the rotating and stationary parts. Eachof these pathways are explained in further detail herein, and forpurposes of discussion and explanation, certain pathways may be shown incombination with one another. It will be appreciated, however, that anyof these pathways may be utilized in any suitable combination with oneanother to permit any suitable number of total signal pathways.Furthermore, as will be explained in further detail below, certainsignal transfer pathways can be more conducive to transmitting eitherpower or other signals, such as ultrasound signals.

Referring to FIG. 3, an embodiment of a rotational IVUS probe 300 havingan interface module 314 and catheter 301 suitable for use with anadvanced transducer technology is represented. As shown, the probe 300has a catheter body 302, a transducer shaft 304, and a catheter hub 316.The catheter body 302 has a proximal end 306 and the transducer shaft304 has a proximal end 310. The catheter hub 316 includes a stationaryexterior housing 324, a dog 326, and a connector 328. The connector 328is represented with six conductive lines 354 shown in this embodiment.It will be appreciated, however, that any suitable number of conductivelines can be utilized.

As shown, the interior of the interface module 314 can include a motor336, a motor shaft 338, a main printed circuit board (PCB) 340, aspinning element 332, and any other suitable components for theoperation of the IVUS probe 300. The motor 336 is connected to the motorshaft 338 to rotate the spinning element 332. The printed circuit board340 can have any suitable number and type of electronic components 342.

The spinning element 332 has a complimentary connector 344 for matingwith the connector 328 on the catheter hub 316. The connector 344 canhave conductive lines, such as 355, that contact the conductive lines,such as 354, on the connector 328. As shown, the spinning element 332 iscoupled to a rotary portion 348 of a rotary transformer 346. The rotaryportion 348 of the transformer 346 passes the signals to and from astationary portion 350 of the transformer 346. The stationary portion350 of the transformer 346 is electrically connected to the printedcircuit board 340.

In this embodiment, the transformer 346 has multiple sets of windingsfor transmitting multiple signals across the transformer 346.Specifically, as shown, the rotary portion 348 and the stationaryportion 350 of the transformer 346 each have two sets of windings, suchas windings 352, 353 on the stationary portion 350 and windings 351, 357on the rotary portion 348, to transmit two signals across thetransformer 346. In this way, more signal pathways are available for aprobe 300 utilizing an advanced transducer technology. It will beappreciated that any suitable number of windings may be used to transmitany suitable number of signals across the transformer 346. Inalternative embodiments, planar flex circuits can be used in place ofthe windings in the transformer. The planar flex circuits can be placedvery close to one another to enhance signal quality.

Another consideration for advanced transducer technologies is that theprobe 300 can benefit from the utilization of certain active electroniccomponents and circuitry in order to facilitate and/or complement theoperation of the transducer. Through active electronic components andcircuitry on the spinning element 332, more complex electricalcommunication can take place between the interface module 314 and thetransducer. Furthermore, by handling certain signal processing functionson the spinning element 332, the number of signals that need to passacross the spinning element 332 can, in some embodiments, be reduced.

As shown, a printed circuit board 356 can be coupled to the spinningelement 332. The printed circuit board 356 can have any suitable numberof electronic components 358 coupled thereto. Any suitable number ofprinted circuit boards 356 having any suitable number and type ofelectronic components 358 can be utilized on the spinning element 332.The electronic components on the spinning element 332 allow for signalprocessing to take place on the spinning side of the probe 300 beforethe signal is communicated across the rotary/stationary boundary.

Typically, advanced transducer technologies require a DC power source.To provide DC power to the transducer, the spinning element 332 can befitted with contacts, such as slip ring contacts 360, 361, which arerespectively engaged by stationary brushes 362, 363 within the interfacemodule 314. Each of the slip rings 360, 361 is coupled to a respectiveconductive line, such as 355, in the connector 344.

In other embodiments, the transducer can be powered by an AC powersource. For example, instead of using brushes and contacts, AC power canbe transmitted through a set of windings in the transformer 346. Oncethe power has passed across from the stationary portion 350 of thetransformer 346 to the rotary portion 348 of the transformer 346, it canbe passed to a power supply circuit, such as a diode rectifier, on thespinning element 332 that rectifies the AC power into DC power. Therectifier can be coupled to the printed circuit board 356 on thespinning element 332 as one of the electronic components 358. After theAC power is converted to DC power, the DC power can be used to power thetransducer, as well as the other electronic components 358 included onprinted circuit board 356.

Turning to FIG. 4, an embodiment of a rotational IVUS probe 400 havingan interface module 414 and catheter 401 suitable for use with anadvanced transducer technology is represented. As shown, the probe 400has a catheter body 402, a transducer shaft 404, and a catheter hub 416.The catheter body 402 has a proximal end portion 406, and the transducershaft 404 has a proximal end portion 410. The catheter hub 416 includesa stationary exterior housing 424, a dog 426, and a connector 428. Theconnector 428 is represented with four conductive lines 454 shown inthis embodiment. It will be appreciated, however, that any suitablenumber of conductive lines can be utilized.

As shown, the interior of the interface module 414 can include a motor436, a motor shaft 438, a main printed circuit board (PCB) 440, aspinning element 432, and any other suitable components for theoperation of the IVUS probe 400. The motor 436 is connected to the motorshaft 438 to rotate the spinning element 432. The printed circuit board440 can have any suitable number and type of electronic components 442.

The spinning element 432 has a complimentary connector 444 for matingwith the connector 428 on the catheter hub 416. The connector 444 canhave conductive lines, such as 455, that contact the conductive lines,such as 454, on the connector 428. As shown, the spinning element 432 iscoupled to a rotary portion 448 of a rotary transformer 446. The rotaryportion 448 of the transformer 446 passes the signals to and from astationary portion 450 of the transformer. The stationary portion 450 ofthe transformer 446 is electrically connected to the printed circuitboard 440.

As shown, the rotary portion 448 and the stationary portion 450 of thetransformer 446 each have a set of windings 451, 452 to transmit asignal across the transformer 446. It will be appreciated that anysuitable number of windings may be used to transmit any suitable numberof signals across the transformer 446. In this embodiment, thetransformer 446 can be used to transfer the ultrasound signal. It willalso be appreciated that a planar flex circuit may be used in place ofone or more of the sets of windings as previously described.

The probe 400 can benefit from the utilization of certain electroniccomponents and circuitry in order to facilitate and/or complement theoperation of the transducer. As shown, one or more printed circuitboards 456, 457 can be coupled to the spinning element 432. The printedcircuit boards 456, 457 can have any suitable number of electroniccomponents, such as 458 and 459, coupled thereto. It will be appreciatedthat any suitable number of printed circuit boards 456, 457 having anysuitable number and type of electronic components 458, 459 can beutilized on the spinning element 432. Electronic components on thespinning element 432 allow for signal processing to take place on thespinning side of the probe 400 before the signal is communicated acrossthe rotary/stationary boundary.

In this embodiment, power is provided to the transducer using agenerator mechanism 464 to generate power locally. As illustrated in thefigure, the generator mechanism 464 includes a generator coil 466 and aplurality of stator magnets 468, 469. The generator coil 466 can beattached to the spinning element 432 to rotate with the spinning element432 and generate power. The power generated is AC power, so a powersupply circuit, such as a diode rectifier, can be used to convert the ACpower into DC power. The rectifier can be coupled to the printed circuitboards 456, 457 on the spinning element 432. After rectification, the DCpower can be used to power the transducer as well as the otherelectronic components 458, 459 included on the printed circuit boards456, 457. It will be appreciated that any suitable generator can beutilized to provide power to the transducer.

Another embodiment of a rotational IVUS probe 500 having an interfacemodule 514 and catheter 501 suitable for use with an advanced transducertechnology is represented in FIG. 5. As shown, the probe has a catheterbody 502, a transducer shaft 504, and a catheter hub 516. The catheterbody 502 has a proximal end portion 506, and the transducer shaft 504has a proximal end portion 510. The catheter hub 516 includes astationary exterior housing 524, a dog 526, and a connector 528. Theconnector 528 is represented with four conductive lines 554 shown inthis embodiment. It will be appreciated, however, that any suitablenumber of conductive lines can be utilized.

As shown, the interior of the interface module 514 can include a motor536, a motor shaft 538, a main printed circuit board (PCB) 540, aspinning element 532, and any other suitable components for theoperation of the IVUS probe 500. The motor 536 is connected to the motorshaft 538 to rotate the spinning element 532. The printed circuit board540 can have any suitable number and type of electronic components 542.

The spinning element 532 has a complimentary connector 544 for matingwith the connector on the catheter hub 516. The connector 544 can haveconductive lines, such as 555, that contact the conductive lines, suchas 554, on the connector 528. As shown, the spinning element 532 iscoupled to a rotary portion 548 of a rotary transformer 546. The rotaryportion 548 of the transformer 546 passes the signals to and from thestationary portion 550 of the transformer 546. The stationary portion550 of the transformer 546 is electrically connected to the printedcircuit board 540.

As shown, the rotary portion 548 and the stationary portion 550 of thetransformer 546 each have one set of windings 551, 552 to transmit asignal across the transformer 546. It will be appreciated that anysuitable number of windings 551, 552 may be used to transmit anysuitable number of signals across the transformer 546. In thisembodiment, the transformer 546 is used to transfer AC power. Once thepower has passed across from the stationary portion 550 of thetransformer 546 to the rotary portion 548 of the transformer 546, it canbe passed to a power supply circuit, such as a diode rectifier, on thespinning element 532 that rectifies the AC power into DC power. Therectifier can be coupled to the printed circuit boards 556, 557 on thespinning element 532. After the AC power is converted to DC power, theDC power can be used to power the transducer as well as the otherelectronic components 558, 559 included on the printed circuit boards556, 557. It will also be appreciated that a planar flex circuit may beused in place of one or more of the sets of windings as previouslydescribed.

As previously mentioned, the probe 500 can benefit from the utilizationof certain electronic components and circuitry in order to facilitateand/or complement the operation of the transducer. As shown, one or moreprinted circuit boards 556, 557 can be coupled to the spinning element532. The printed circuit boards 556, 557 can have any suitable number ofelectronic components, such as 558 and 559, coupled thereto. It will beappreciated that any suitable number of printed circuit boards 556, 557having any suitable number and type of electronic components 558, 559can be utilized on the spinning element 532. Electronic components 558,559 on the spinning element 532 allow for signal processing to takeplace on the spinning side of the probe 500 before the signal iscommunicated across the rotary/stationary boundary.

In this embodiment, an optical coupler 570 is used to transmit theultrasound signal. It will be appreciated that any suitable opticalcoupler may be used. The optical coupler can have a first end 572 and asecond end 574. The first end 572 can be stationary and receive opticalsignals from the second end 574, which can be coupled directly orindirectly to the spinning element 532. The ultrasound signal can betransmitted to circuitry on the printed circuit board 540 or can becarried external to the interface module 514.

One illustrative example of how the ultrasound signal could becommunicated over this optical path is that the printed circuit boards556, 557 could include a high speed analog to digital converter (ADC)among electronic components 558, 559. This ADC would be used to digitizethe ultrasound echo signal and convert the resultant digital data into aserial bit stream. This serial data would then be provided to an opticaltransmitter, such as a laser diode circuit, also included on printedcircuit boards 558, 559 to transmit the high-speed serial bit streamover the rotating optical coupler 570 to an optical receiver circuitincluded on printed circuit board 540 or located remotely from theinterface module 514.

As shown, a structure may be provided that can provide feedback as tothe angular position of the transducer. For example, an optical device576 may be provided that includes a stationary encoder wheel 578 and anoptical detector 580. The optical detector 580 can be attached to aprinted circuit board 557 on the spinning element 532.

Another embodiment of a rotational IVUS probe 600 having an interfacemodule 614 and catheter 601 suitable for use with an advanced transducertechnology is represented in FIG. 6. As shown, the probe 600 has acatheter body 602, a transducer shaft 604, and a catheter hub 616. Thecatheter body 602 has a proximal end portion 606, and the transducershaft 604 has a proximal end portion 610. The catheter hub 616 includesa stationary exterior housing 624, a dog 626, and a connector 628. Theconnector is represented with four conductive lines, such as 654, shownin this embodiment. It will be appreciated, however, that any suitablenumber of conductive lines 654 can be utilized.

As shown, the interior of the interface module 614 can include a motor636, a motor shaft 638, a main printed circuit board (PCB) 640, aspinning element 632, and any other suitable components for theoperation of the IVUS probe 600. The motor 636 is connected to the motorshaft 638 to rotate the spinning element 632. The main printed circuitboard 640 can have any suitable number and type of electronic components642 including but not limited to the transmitter and the receiver forthe transducer.

The spinning element 632 has a complimentary connector 644 for matingwith the connector 628 on the catheter hub 616. The connector 644 canhave conductive lines, such as 655, that contact the conductive lines,such as 654, on the connector 628. As shown, the spinning element 632 iscoupled to a rotary portion 648 of a rotary transformer 646. The rotaryportion 648 of the transformer 646 passes the signals to and from thestationary portion 650 of the transformer 646. The stationary portion650 of the transformer 646 is electrically connected to the printedcircuit board 640.

As shown, the rotary portion 648 and the stationary portion 650 of thetransformer 646 each have a set of windings 651, 652 to transmit asignal across the transformer 646. It will be appreciated that anysuitable number of windings may be used to transmit any suitable numberof signals across the transformer 646. In this embodiment, thetransformer 646 is used to transfer AC power. Once the power has passedacross from the stationary portion 650 of the transformer 646 to therotary portion 648 of the transformer 646, it can be passed to a powersupply circuit, such as a diode rectifier, on the spinning element 632that rectifies the AC power into DC power. The rectifier can be coupledto printed circuit boards 656, 657 on the spinning element 632. Afterthe AC power is converted to DC power, the DC power can be used to powerthe transducer as well as the other electronic components 658, 659included on the printed circuit boards 656, 657. It will also beappreciated that a planar flex circuit may be used in place of one ormore of the sets of windings as previously described.

As previously mentioned, the probe can benefit from the utilization ofcertain electronic components and circuitry in order to facilitateand/or complement the operation of the transducer. As shown, one or moreprinted circuit boards 656, 657 can be coupled to the spinning element632. The printed circuit boards 656, 657 can have any suitable number ofelectronic components, such as 658 and 659, coupled thereto. It will beappreciated that any suitable number of printed circuit boards 656, 657having any suitable number and type of electronic components 658, 659can be utilized on the spinning element 632. Electronic components 658,659 on the spinning element 632 allow for signal processing to takeplace on the spinning side of the probe 600 before the signal iscommunicated across the rotary/stationary boundary.

In this embodiment, a wireless communication mechanism is used totransmit the ultrasound signal. Any suitable wireless communicationmechanism may be used including, but not limited to, wireless mechanismsutilizing radio frequency or infrared. As shown, the wirelesscommunication mechanism includes transmitter and/or receiver components682 and 684. The transmitter and/or receiver component 682 can beattached to any suitable location such as the printed circuit board 657on the spinning element 632. The transmitter and/or receiver component684 can likewise be placed in any suitable location including the mainprinted circuit board 640 in the interface module 614.

Therefore, it will be appreciated that signals can be carried across therotating and stationary mechanical components via any suitable mechanismincluding, but not limited to, a transformer, an optical coupler, awireless communication mechanism, a generator, and/or brushes/contacts.In certain embodiments, a transformer, an optical coupler, and/or awireless communication mechanism can be utilized to carry signals suchas an ultrasound signal. In certain embodiments, a transformer, a powergenerator, and/or brushes/contacts can be utilized to convey power tothe transducer.

Furthermore, the spinning element can have one or more printed circuitboards with a suitable number and type of active electronic componentsand circuitry, thus making the spinning element an active spinningelement. Examples of electronic components that can be utilized with theactive spinning element include, but are not limited to, power supplycircuits (such as a generator, rectifier, regulator, high voltagestep-up converter, etc.), transmitters (including tripolartransmitters), time-gain-control (TGC) amplifiers, amplitude and/orphase detectors, ADC converters, optical transceivers, encoder circuits,wireless communication components, microcontrollers, and any othersuitable components. In addition, the spinning element can includeencoder and timing logic such that it can internally generate thetransmit triggers, and thus, eliminate the need to communicate a timingsignal across the spinning element. Through the embodiments describedherein, excellent image quality is possible including wide bandwidth,frequency-agility, low ringdown, focused beam (including dynamicallyfocused beam), and harmonic capability.

As mentioned, any suitable advanced transducer technology may be used,including but not limited to PMUT and CMUT transducers, either as singletransducers or arrays. As an example, a PMUT transducer can be formed bydepositing a piezoelectric polymer (such as polyvinylidenefluoride—PVDF) onto a micromachined silicon substrate. The siliconsubstrate can include an amplifier and protection circuit to buffer thesignal from the PVDF transducer. It can be important to include theamplifier immediately adjacent to the PVDF element because thecapacitance of the electrical cables can dampen the signal from the highimpedance PVDF transducer. The amplifier typically requires DC power,transmit input(s), and amplifier output connections. The PVDF transducercan be a focused transducer to provide excellent resolution.

As mentioned above, having an active spinning element, such as isdescribed herein, permits the utilization of an advanced transducertechnology on a rotational IVUS probe. In addition, having an activespinning element can facilitate certain advanced operations of theprobe. The enhanced bandwidth of the probe utilizing the active spinnerpermits the probe to obtain information at a plurality of differentfrequencies. By way of example and not limitation, the probe can beutilized to obtain ultrasound information taken at two diversefrequencies, such as 20 MHz and 40 MHz. It will be appreciated that anysuitable frequency and any suitable quantity of frequencies may be used.

Generally, lower frequency information facilitates a tissue versus bloodclassification scheme due to the strong frequency dependence of thebackscatter coefficient of the blood. Higher frequency informationgenerally provides better resolution at the expense of poordifferentiation between blood speckle and tissue, which can make itdifficult to identify the lumen border. Thus, if information is obtainedat a lower frequency and a higher frequency, then an algorithm can beutilized to interleave and display the two data sets to obtainfrequency-diverse information that is closely aligned in time and space.In result, a high resolution ultrasound image can be produced with cleardifferentiation between blood and tissue and accurate delineation ofvessel borders.

The typical 512 A-lines that compose a single frame of an image can beinterspersed into alternating high and low frequency A-lines. As anexample, a 20 MHz image can show the blood as black and the tissue asgray, while the 40 MHz image can show the blood and tissue as gray andbarely, if at all, distinguishable from one another. It can berecognized through a provided algorithm that black in 20 MHz and gray at40 MHz is blood, gray at both frequencies is tissue, and black at bothfrequencies is clear fluid. The broadband capability of advancedtransducer technologies, such as PMUT, facilitated by the activespinning element, can allow for closely interleaved A-lines of two ormore different center frequencies, possibly including pulse-inversionA-line pairs to generate harmonic as well as fundamental information,which is then combined to provide a robust classification scheme fortissue versus blood.

The dual frequency blood classification scheme can be further enhancedby other blood speckle reduction algorithms such as motion algorithms(such as ChromaFlo, Q-Flow, etc.), temporal algorithms, harmonic signalprocessing, etc. It will be appreciated that any suitable algorithm canbe used.

Besides intravascular ultrasound, other types of ultrasound catheterscan be made using the teachings provided herein. By way of example andnot limitation, other suitable types of catheters includenon-intravascular intraluminal ultrasound catheters, intracardiac echocatheters, laparoscopic, and interstitial catheters. In addition, theprobe may be used in any suitable anatomy, including, but not limitedto, coronary, carotid, neuro, peripheral, or venous.

Recitation of ranges of values herein are merely intended to serve as ashorthand method of referring individually to each separate valuefalling within the range, unless otherwise indicated herein, and eachseparate value is incorporated into the specification as if it wereindividually recited herein.

It will be appreciated that like reference numbers and/or like shownfeatures in the figures can represent like features. It will beappreciated that discussions of like reference numbers and/or like shownfeatures in any embodiment may be applicable to any other embodiment.

Any references, including publications, patent applications, andpatents, cited herein are hereby incorporated by reference to the sameextent as if each reference were individually and specifically indicatedto be incorporated by reference and were set forth in its entiretyherein (including any references contained therein).

Illustrative embodiments of a rotational IVUS probe incorporating anadvanced ultrasound transducer technology are described herein.Variations of the disclosed embodiments will be apparent to those ofordinary skill in the art in view of the foregoing illustrativeexamples. Those skilled in the relevant art will employ such variationsas appropriate, and such variations, embodied in alternativeembodiments, are contemplated within the scope of the disclosedinvention. The invention is therefore not intended to be limited to theexamples described herein. Accordingly, this invention includes allmodifications and equivalents of the subject matter recited in theclaims appended hereto as permitted by applicable law. Moreover, anycombination of the above-described elements in all possible variationsthereof is encompassed by the invention unless otherwise indicatedherein or otherwise clearly contradicted by context.

What is claimed is:
 1. A rotational intravascular ultrasound probe forinsertion into a vasculature, the probe comprising: an elongate catheterhaving a flexible body, an elongate transducer shaft disposed within theflexible body, the transducer shaft having a drive cable and atransducer coupled to the drive cable adjacent a distal portion of theflexible body, and a proximal connector adjacent a proximal portion ofthe flexible body; and an interface module configured to interface withthe proximal connector of the elongate catheter, the interface moduleincluding: a spinning element configured to be fixedly coupled to aproximal portion of the transducer shaft, the spinning element having anelectronic component coupled thereto such that when the spinning elementis fixedly coupled to the proximal portion of the transducer shaft theelectronic component is in electrical contact with the transducer; astationary element positioned adjacent to and spaced from the spinningelement, wherein the stationary element is configured to pass signals tothe spinning element and receive signals from the spinning element; anda motor coupled to the spinning element for rotating the spinningelement and the transducer shaft when the spinning element is fixedlycoupled to the proximal portion of the transducer shaft.
 2. Therotational intravascular ultrasound probe of claim 1 wherein thespinning element has a printed circuit board, and the electroniccomponent is attached to the printed circuit board.
 3. The rotationalintravascular ultrasound probe of claim 1 wherein the transducer is aPMUT transducer.
 4. The rotational intravascular ultrasound probe ofclaim 1 wherein the transducer is a CMUT transducer.
 5. The rotationalintravascular ultrasound probe of claim 1 wherein the spinning elementincludes a generator for generating power for the transducer.
 6. Therotational intravascular ultrasound probe of claim 1 wherein theelectronic component is selected from the group consisting of atransmitter, a time-gain-control amplifier, an amplitude detector, aphase detector, an analog to digital converter, an optical transceiver,an encoder circuit, a wireless communication component, and amicrocontroller.
 7. The rotational intravascular ultrasound probe ofclaim 1 further comprising a printed circuit board having an algorithmstored thereon for interleaving data obtained at different frequenciesfrom the transducer.
 8. The rotational intravascular ultrasound probe ofclaim 1 further comprising at least three conductive lines electricallyconnecting the spinning element to the transducer.
 9. An interfacemodule for a rotational intravascular ultrasound probe for insertioninto a vasculature, the interface module comprising: a connector forattachment to a proximal portion of a catheter having a transducer shaftwith a transducer, the connector configured to fixedly engage with thetransducer shaft such that the connector is in electrical communicationwith the transducer; a spinning element fixedly coupled to theconnector, the spinning element having an electronic component coupledthereto that is in electrical contact with the connector such that whenthe connector is fixedly engaged with the transducer shaft theelectronic component is in electrical communication with the transducer;a stationary element positioned adjacent to and spaced from the spinningelement, wherein the stationary element is configured to pass signals tothe spinning element and receive signals from the spinning element; amotor coupled to the spinning element for rotating the spinning elementand the connector such that, when the connector is fixedly engaged withthe transducer shaft, the transducer shaft rotates with the spinningelement and the connector; and a housing, wherein at least the spinningelement, stationary element, and motor are positioned within thehousing.
 10. The interface module of claim 9 wherein the spinningelement has a printed circuit board, and the electronic component isattached to the printed circuit board.
 11. The interface module of claim9 wherein the spinning element is attached to an optical coupler. 12.The interface module of claim 9 wherein the spinning element includes aslip ring contact for a brush.
 13. The interface module of claim 9wherein the spinning element includes a generator for generating powerfor the transducer.
 14. The interface module of claim 9 wherein theelectronic component is selected from the group consisting of atransmitter, a time-gain-control amplifier, an amplitude detector aphase detector, an analog to digital converter, an optical transceiver,an encoder circuit, a wireless communication component, and amicrocontroller.
 15. The interface module of claim 9 further comprisinga printed circuit board having an algorithm stored thereon forinterleaving data obtained at different frequencies from the transducer.16. The interface module of claim 9 wherein the connector includes atleast three conductive lines electrically connected to the spinningelement.
 17. An interface module for a rotational intravascularultrasound probe for insertion into a vasculature, the interface modulecomprising: a housing; a printed circuit board positioned within thehousing; a connector for attachment to a proximal portion of a catheterhaving a transducer shaft with a transducer, the connector configured tofixedly engage with the transducer shaft such that the connector is inelectrical communication with the transducer; a spinning element fixedlycoupled to the connector, the spinning element having more than twosignal pathways electrically connecting the spinning element to theconnector such that when the connector is fixedly engaged with thetransducer shaft at least one of the two signal pathways electricallyconnects the spinning element to the transducer; a stationary elementpositioned within the housing adjacent to and spaced from the spinningelement, wherein the stationary element is configured to pass signals tothe spinning element and receive signals from the spinning element, thestationary element electrically coupled to the printed circuit board;and a motor positioned within the housing and coupled to the spinningelement for rotating the spinning element and the connector such that,when the connector is fixedly engaged with the transducer shaft, thetransducer shaft rotates with the spinning element and the connector.18. The interface module of claim 17 wherein the spinning elementincludes at least one of a rotary transformer, a slip ring contact for abrush, a power generator, a wireless communication component, and anoptical communication component.
 19. A rotational intravascularultrasound device, the device comprising: an elongate catheter having aflexible body, an elongate transducer shaft disposed within the flexiblebody, and at least one transducer coupled to the transducer shaftadjacent a distal portion of the flexible body; a connector fixedlysecured to a proximal portion of the transducer shaft such that theconnector is in electrical communication with the at least onetransducer; a spinning element fixedly coupled to the connector, thespinning element having planar flex circuit coupled thereto, wherein thespinning element is in electrical contact with the connector such thatwhen the connector is fixedly secured to the proximal portion of thetransducer shaft the planar flex circuit is in electrical communicationwith the at least one transducer; and a stationary element positionedadjacent to and spaced from the spinning element, the stationary elementincluding a planar flex circuit configured to pass signals to the planarflex circuit of the spinning element and receive signals from the planarflex circuit of the spinning element.
 20. The rotational ultrasounddevice of claim 19, further comprising a housing, wherein at least thespinning element and the stationary element are positioned within thehousing.